Re: Docket No. FDA–2016–D–2268: Insanitary Conditions at Compounding Facilities; Draft Guidance for Industry; Availability Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance entitled “Insanitary Conditions at Compounding Facilities” (Draft Guidance).BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial, and environmental biotechnology products. GENERAL COMMENTS: BIO applauds the issuance by the FDA of this Draft Guidance as it recognizes the importance of sanitary conditions within compounding facilities. BIO also recognizes the inherent challenges that the FDA faces in regulating a safe and sterile environment for compounding as most compounding pharmacies do not register as 503B outsourcing facilities. Thus, we are pleased to see that the FDA encourages state regulators to pay close attention to the cleanliness of compounding pharmacy operations and to take action where necessary.Similarly, BIO believes that the current Draft Guidance could go even further to convey the importance of this issue with state regulatory agencies. Under section 501(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), a drug is deemed to be adulterated “if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.” A February 2016 report from the Pew Charitable Trusts entitled, “National Assessment of State Oversight of Sterile Drug Compounding,” highlighted significant state deficiencies regarding oversight of sanitary compounding…

The undersigned organizations support the inclusion of $3 million within the Fiscal Year 2017 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act to better inform the public about the application of biotechnology to food and agricultural production...

Why the focus on intellectual property fails to address the complexities of medicinal access in IndiaStephen M. Sammut and Daniel S. LevineReleased in San Francisco, June, 2016Supported by and prepared for the Biotechnology Innovation Organization and the Association of Biotechnology Led EnterprisesThe opinions expressed in this paper are those of the authors and do not necessarily reflect the opinions of BIO and ABLE.

BIO submits comments to submits comments in response to the Notice of a Request for Information, published by the National Science and Technology Council, Science and Technology Policy Office. Comments were submitted to Food and Drug Administration Docket No. FDA-2015-N-3403; Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the Regulation of the Products of Biotechnology.

The Biotechnology Innovation Organization along with the American Farm Bureau Federation sent a letter to the House of Representatives and Senate Appropriations Committees urging the Committees to oppose any provision related to bioengineered food labeling, including salmon labeling, that may come up for consideration during the Fiscal Year 2017 appropriations process. 

BIO submitted comments on the Institute for Clinical and Economic Review (ICER) Value Assessment Framework. Throughout the attached letter, BIO addresses issues it has raised previously with the Framework as well as responds specifically to the four major categories of issues that the Institute identified (in the order in which they were identified).